becaplermin

Therapeutic Classification: wound/ulcer/decubiti healing agent

Pharmacologic Classification: platelet derived growth factors

Indications ⬆ ⬇

REMS

Lower extremity diabetic neuropathic ulcers extending to SUBQ tissue or beyond and having adequate blood supply.

Action ⬆ ⬇

Promotes chemotaxis of cells involved in wound repair and enhances formation of granulation tissue.

Therapeutic effects:

Improved healing.

Pharmacokinetics ⬆ ⬇

Absorption: Minimal absorption (<3%).

Distribution: Action is primarily local.

Metabolism/Excretion: Unknown.

Half-Life: Unknown.

Time/Action Profile ⬆ ⬇

(improvement in ulcer healing)

ROUTE	ONSET	PEAK	DURATION
Topical	within 10 wk	unknown	unknown

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Known hypersensitivity to becaplermin or parabens;
Known neoplasm at site of application;
Wounds that close by primary intention.

Use Cautiously in:

Known malignancy;
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Children <16 yr (safety and effectiveness not established).

Adv. Reactions/Side Effects ⬆ ⬇

Derm: erythematous rash at application site

Misc: MALIGNANCY

Interactions ⬆ ⬇

Drug-drug:

None reported.

Route/Dosage ⬆ ⬇

(Adults and Children ≥16 yr): Length of gel in inches from 15- or 7.5-g tube = length × width of ulcer area × 0.6; from the 2-g tube = length × width of ulcer area × 1.3. Length of gel in centimeters from 15- or 7.5-g tube = length × width of ulcer area ÷ 4; from the 2-g tube = length × width of ulcer area ÷ 2; for 12 hr each day.

Availability ⬆ ⬇

Assessment ⬆ ⬇

Assess size, color, drainage, and skin surrounding wound at weekly or biweekly intervals. Amount of gel to be applied is recalculated based on wound size.

Implementation ⬆ ⬇

Topical Calculated amount is applied as a thin layer (1/16 in. thick) and covered with a moist saline dressing for 12 hr; dressing is removed, ulcer rinsed and redressed with moist dressing without becaplermin for rest of day. Process is repeated daily.
- Store gel in refrigerator; do not freeze. Do not use beyond expiration date on crimped end of tube.

Patient/Family Teaching ⬆ ⬇

Instruct patient on proper technique for application. Wash hands before applying gel and use cotton swab or tongue depressor to aid in application. Tip of tube should not come in contact with ulcer or any other surface; recap tightly after each use. Squeeze calculated amount of gel onto a clean, firm, nonabsorbable surface (wax paper). Spread gel with swab or tongue depressor over the ulcer surface in an even layer to the thickness of a dime. Cover with a saline-moistened gauze dressing.
- Do not apply more than calculated amount; has not been shown to be beneficial. If a dose is missed, apply as soon as remembered. If not remembered until next day, skip dose and return to regular dosing schedule. Do not double doses.
- After 12 hr, rinse ulcer gently with saline or water to remove residual gel and cover with saline-moistened gauze.
Emphasize the importance of strict wound care and non–weight-bearing program.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

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Pronunciation ⬇

Classifications ⬆ ⬇